ELECTROSURGICAL ELECTRODE FAMILY

K992045 · Genesis Medical, Inc. · GEI · Jan 27, 2000 · General, Plastic Surgery

Device Facts

• Record ID: K992045
• Device Name: ELECTROSURGICAL ELECTRODE FAMILY
• Applicant: Genesis Medical, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jan 27, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indicated for coagulation of tissue These devices are intended for use by qualified medical personnel trained in the use of electrosurgery.

Device Story

Genesis Medical Electrosurgical Electrode Family (Models 4400, 4110, 4002) consists of multi-needle electrodes featuring irrigation, aspiration, and optional sponge components. Devices are used by trained medical personnel in clinical settings to perform tissue coagulation via electrosurgery. The device delivers electrical energy to target tissue to achieve hemostasis or tissue destruction. The inclusion of irrigation and aspiration capabilities allows for site management during the procedure. The device is intended for prescription use only.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrosurgical electrode family including multi-needle configurations, balloons, irrigation/aspiration channels, and optional sponges. Energy source: electrosurgical generator (not included).

Indications for Use

Indicated for coagulation of tissue. Intended for use by qualified medical personnel trained in electrosurgery. Contraindicated when, in the physician's judgment, electrosurgical procedures are contrary to the patient's best interest.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Submission Summary (Full Text)

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## JAN 2 7 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Thomas C. Wehman, Ph.D. Regulatory Affairs Genesis Medical, Inc. 524 Weddell Drive, Suite 4 Sunnyvale, California 94089

Re: K992045

Trade Name: Genesis Medical, Inc. Electrosurgical Electrode Family:

Model 4400 - Four Needle Electrode Single Balloon, Irrigation and Aspiration with Sponge option Model 4400 - Four Needle Electrode Single Balloon, Irrigation and Aspiration without Sponge option

Model 4110 - Four Needle Electrode Dual Balloons, Irrigation and Aspiration with Sponge option

Model 4110 - Four Needle Electrode Dual Balloons, Irrigation and Aspiration without Sponge option

Model 4002 - Four Needle Electrode, Guidewire, Irrigation and Aspiration with Sponge option

Model 4002 - Four Needle Electrode, Guidewire, Irrigation and Aspiration without Sponge option

Regulatory Class: II Product Code: GEI Dated: November 8, 1999 Received: November 17, 1999

Dear Dr. Wehman:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good

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## Page 2 - Thomas C. Wehman, Ph.D.

Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device. please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely vours.

Stpt. Riverda

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| 510(k) Number (if known): | Unknown K992045 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Genesis Medical, Inc. Electrosurgical Electrode Family |
| Indications for Use: | Indicated for coagulation of tissue |
| | These devices are intended for use by qualified medical personn-<br>trained in the use of electrosurgery. |
| Contraindications: | The use of electrosurgery is contraindicated when, in the<br>judgment of the physician, electrosurgical procedures would<br>be contrary to the best interest of the patient. |

## Indications For Use

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Concurrence of CDRH, Office of Device Evaluation (ODE)

*Stigh Ploder*

(Division Sign-Off)

Division of General Restorative Devices 5 : 0(k) Number ______________________________________________________________________________________________________________________________________________________________

OR

Over-the-Counter Use (Optional format 1-2-96)

Prescription Use
(per 21 CFR 801.109)

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